Efficacy of Ziprasidone Augmentation of Escitalopram for Cognitive Symptoms of Major Depressive Disorder.
Efficacy of Ziprasidone Augmentation of Escitalopram for Cognitive Symptoms of Major Depressive Disorder.
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DOI：
10.4088/jcp.16m10920
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发表时间：
2017-07
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影响因子：
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通讯作者：
N. Iovieno;R. Shelton;S. Petrie;C. Cusin;M. Fava;G. Papakostas
中科院分区：
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作者：
N. Iovieno;R. Shelton;S. Petrie;C. Cusin;M. Fava;G. Papakostas
目的 研究辅助齐拉西酮治疗成年重度抑郁症 (MDD) 患者在接受开放标签艾司西酞普兰 8 周后出现持续症状的认知症状的疗效。方法 这项事后分析是对源自先前发表的研究的数据库进行的。母研究是一项多中心、平行、随机、双盲、安慰剂对照试验，于 2008 年 7 月至 2013 年 10 月在美国 3 个学术医疗中心进行。参与者池由 139 名患有持续性 MDD 症状的门诊患者组成，根据 DSM-IV 标准，经过为期 8 周的开放标签、灵活剂量艾司西酞普兰试验。受试者被随机分配（1:1，N = 139）接受固定剂量齐拉西酮辅助治疗（艾司西酞普兰 + 齐拉西酮，n = 71）或辅助安慰剂（艾司西酞普兰 + 安慰剂，n = 68），并进行 8 周随访评估。主要结果是根据 17 项汉密尔顿抑郁评定量表的临床反应，其定义为量表分数降低 50% 或更多。马萨诸塞州总医院认知和身体功能问卷（CPFQ）用于测量每次研究访视时的认知和执行功能障碍。所有统计检验均在标称、双面、0.05 显着性水平下进行。结果 与辅助安慰剂相比，辅助齐拉西酮治疗并未导致 CPFQ 评分显着改善 (P > .05)。据报道，大量被认为对辅助齐拉西酮或安慰剂有反应的患者出现了残余认知症状。结论 在本研究中，与辅助安慰剂相比，齐拉西酮与选择性 5-羟色胺再摄取抑制剂艾司西酞普兰辅助治疗 MDD 患者的认知症状并未表现出更大的疗效。未来，有必要进行精心设计的研究，检验非典型抗精神病药物或其他增强与转换策略对 MDD 认知症状的作用。
OBJECTIVE To examine the efficacy of adjunctive ziprasidone for cognitive symptoms in adult patients with major depressive disorder (MDD) experiencing persistent symptoms after 8 weeks of open-label escitalopram. METHODS This post hoc analysis was conducted on a database derived from a previously published study. The parent study was a multicenter, parallel, randomized, double-blind, placebo-controlled trial conducted at 3 academic medical centers in the United States from July 2008 to October 2013. The participant pool consisted of 139 outpatients with persistent symptoms of MDD, according to DSM-IV criteria, following an 8-week open label, flexible-dose trial of escitalopram. Subjects were randomly assigned (1:1, N = 139) to adjunctive fixed-dose ziprasidone (escitalopram + ziprasidone, n = 71) or adjunctive placebo (escitalopram + placebo, n = 68) with 8 weekly follow-up assessments. Primary outcome was clinical response according to the 17-item Hamilton Depression Rating Scale, which was defined as a 50% or greater reduction in scale scores. The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) was used to measure cognitive and executive dysfunction at each study visit. All statistical testing was conducted at the nominal, 2-sided, 0.05 level of significance. RESULTS Adjunctive ziprasidone therapy did not result in significantly greater improvement in CPFQ scores compared to adjunctive placebo (P > .05). Residual cognitive symptoms were reported in a substantial number of patients who were considered responders to either adjunctive ziprasidone or placebo. CONCLUSIONS In the present study, ziprasidone used adjunctively with the selective serotonin reuptake inhibitor escitalopram did not demonstrate a greater efficacy for cognitive symptoms in patients with MDD compared with adjunctive placebo. Future, well-designed studies examining the role of atypical antipsychotics or other augmentation versus switch strategies for cognitive symptoms in MDD are warranted.